A Survey of Near-Miss Dispensing Errors in Hospital Pharmacies in Japan: DEPP-J Study-Multi-Center Prospective Observational Study-

The aim of this study was to determine the proportion of near-miss dispensing errors in hospital pharmacies in Japan. A prospective multi-center observational study was conducted between December 2018 and March 2019. The primary objective was to determine the proportion of near-miss dispensing errors in hospital pharmacy departments. The secondary objective was to determine the predictive factors for near-miss dispensing errors using multiple logistic regression analysis. The study was approved by the ethical committee at The Institute of Medical Sciences, University of Tokyo, Japan. A multi-center prospective observational study was conducted in 20 hospitals comprising 8862 beds. Across the 20 hospitals, we assessed data from 553 pharmacists and 53039 prescriptions. A near-miss dispensing error proportion of 0.87% (n = 461) was observed in the study. We found predictive factors for dispensing errors in day-time shifts: a higher number of drugs in a prescription, higher number of quantified drugs, such as liquid or powder formula, in a prescription, and higher number of topical agents in a prescription; but we did not observe for career experience level for clinical pharmacists. For night-time and weekend shifts, we observed a negative correlation of near-miss dispensing errors with clinical pharmacist experience level. We found an overall incidence of near-miss dispensing errors of 0.87%. Predictive factors for errors in night-time and weekend shifts was inexperienced pharmacists. We recommended that pharmacy managers should consider education or improved work flow to avoid near-miss dispensing errors by younger pharmacists, especially those working night or weekend shifts.

Risk factors for venous irritation in patients receiving vinorelbine: a retrospective study.

BACKGROUND: Vinorelbine is known to be effective in the treatment of non-small cell lung cancer and breast cancer. However, venous irritation is a common side effect. Although there have been some reports on risk factors for venous irritation in patients receiving vinorelbine, the factors evaluated have been limited and the results inconclusive. The aim of this study was to identify risk factors for venous irritation in patients receiving vinorelbine, and factors likely associated with venous irritation, including new factors such as hot compress with a hot towel  for prevention of venous irritation. METHODS: We retrospectively reviewed patients treated with vinorelbine at Kyorin University Hospital, Japan, between March 2013 and December 2016 and divided them into the two groups according to whether or not they had venous irritation. Clinical characteristics were compared between the two groups. RESULTS: Venous irritation occurred in 24 (38.1%) of 63 patients who received vinorelbine. The median number of times vinorelbine was administered before onset of venous irritation was 3 (range 1-14). The group with venous irritation had a significantly lower body surface area than the group without venous irritation (p = 0.035). Low body surface area was also the only significant risk factor for vinorelbine-associated venous irritation in multivariate analysis (adjusted odds ratio 70.42 per 1 m2decrement, 95% confidence interval 1.54-3236.25, p = 0.029). There was no association between the occurrence of venous irritation and the other covariates, such as use of a hot compress, history of diabetes mellitus, or use of a generic formulation of vinorelbine. CONCLUSION: Low body surface area may be a risk factor for venous irritation in patients receiving vinorelbine. Use of hot compress with a hot towel did not prevent venous irritation.

[Role of Pharmacists in Completion of Adjuvant Cisplatin-Vinorelbine Chemotherapy in Japanese Patients with Non-small Cell Lung Cancer].

　Adjuvant cisplatin-vinorelbine chemotherapy has been shown to be effective in patients with completely resected non-small cell lung cancer (NSCLC) in several Phase III trials, but not yet in the Japanese population. Pharmacists are expected to assist patients with completion of adjuvant chemotherapy. The aim of this retrospective study was to evaluate the compliance with and safety of adjuvant cisplatin-vinorelbine chemotherapy in Japanese patients and to evaluate the contribution of pharmacists to completion of treatment. Thirty-four patients with NSCLC who received adjuvant cisplatin-vinorelbine chemotherapy at Kyorin University Hospital between January 2006 and June 2015 were reviewed. The treatment schedule comprised cisplatin 80 mg/m2 on day 1 and vinorelbine 25 mg/m2 on days 1 and 8 every 3 weeks. Four 3-week cycles were planned. A pharmacist provided guidance to all patients and monitored them for adverse effects thereafter. The pharmacist intervened with advice to doctors as necessary. The 4 cycles were administered in 67.6% of cases. There were no treatment-related deaths. The main grade 3 or 4 toxicities were neutropenia (76.5%) and anorexia (38.2%). The most common reason for discontinuation and dose reduction was anorexia. There were 56 instances of pharmacist intervention. In total, 96.4% of the pharmacist interventions were implemented by doctors, which included administration of an antiemetic on 15 occasions and hot fomentation for prevention of vasculitis on 7 occasions. Adjuvant cisplatin-vinorelbine chemotherapy was tolerated by most patients but was discontinued because of adverse events in some. Pharmacist intervention aids completion of planned chemotherapy and management of treatment-related adverse events.

Risk Factors for Chest Pain and Fever in Patients Undergoing Pleurodesis with OK-432.

Objective In Japan, pleurodesis is often performed using OK-432. However, OK-432 may cause severe chest pain and fever. The risk factors for these complications are unclear. The aim of this study was to identify the risk factors for chest pain and fever caused by pleurodesis with OK-432. Methods The clinical data of 94 patients who underwent pleurodesis with OK-432 were retrospectively analyzed. Patients who developed chest pain (indicated by a record of rescue pain medication) and/or fever (a recorded temperature of >38°C) were identified. A logistic regression analysis was performed to determine the risk factors for these complications. Results Rescue medication for chest pain was required by 43.6% of the patients and 40.4% developed pyrexia after pleurodesis with OK-432. The univariate analysis showed that the likelihood of requiring rescue medication for chest pain was significantly increased in patients of <70 years of age (p=0.028) and in those who were not premedicated with a nonsteroidal anti-inflammatory drug (NSAID; p=0.003). Age <70 years (adjusted odds ratio 2.97, 95% confidence interval 1.10-8.00, p=0.031) and a lack of premedication with an NSAID (adjusted odds ratio 4.21, 95% confidence interval 1.47-12.04, p=0.007) remained significant factors in a multivariate analysis. The absence of NSAID premedication was the only statistically significant risk factor for fever in the univariate analysis (p=0.034). The multivariate analysis revealed no significant risk factors for fever. Conclusion The results of the present study suggest that premedication with an NSAID might be useful for preventing the chest pain caused by pleurodesis with OK-432. Furthermore, caution is advised when managing chest pain in adults of <70 years of age. Prospective studies should be performed to further investigate this issue.